ANTACID - aluminum hydroxide, magnesium hydroxide, simethicone liquid 
Retail Business Services, LLC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Careone Maximum Strength Antacid Liquid

ACTIVE INGREDIENT (in each 10 mL )

Aluminum hydroxide (equiv. to dried gel, USP) 800 mg
Magnesium hydroxide 800 mg
Simethicone 80 mg

PURPOSE

Antacid
Antacid
Antigas

USE(S)

relieves:


WARNINGS

Do not take more than 60 mL in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

ASK A DOCTOR BEFORE USE IF YOU HAVE

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE 

STOP USE AND ASK DOCTOR

if symptoms last more than two weeks

KEEP OUT OF REACH OF CHILDREN

.

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

ethyl alcohol, flavor, glycerin, hydroxyethyl cellulose, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol

PRINCIPAL DISPLAY PANEL

CAREONE
NDC 72476-516-05

Compare to the active ingredients in Mylanta® Maximum Strength

MAXIMUM STRENGTH

ANTACID LIQUID


Aluminum Hydroxide 800mg

Magnesium Hydroxide 800mg

Simethicone 80mg


Original Flavor


Relieves: 

Acid Indigestion, Pressure & Bloating (Gas)

 


12 FL OZ (355 mL)
Alcohol content 0.2% v/v 

79


ANTACID 
aluminum hydroxide, magnesium hydroxide, simethicone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-516
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE800 mg  in 10 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE800 mg  in 10 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINT (Lemon Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72476-516-05355 mL in 1 BOTTLE; Type 0: Not a Combination Product05/27/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33105/27/2021
Labeler - Retail Business Services, LLC. (967989935)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276MANUFACTURE(72476-516)

Revised: 5/2021
Document Id: ce2edc57-e550-4aa9-bbfe-37933913c9eb
Set id: ce2edc57-e550-4aa9-bbfe-37933913c9eb
Version: 1
Effective Time: 20210527
 
Retail Business Services, LLC.